Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma


This is a phase 1b, open-label, multicenter, dose-escalation study of STI-6129 administered intravenously once in a 4-week cycle in subjects with relapsed or refractory multiple myeloma.

SparkCures ID 1253
Trial Phase Phase 1/2
Enrollment 72 Patients
  • STI-6129
Trial Sponsors
  • Sorrento Therapeutics, Inc.
NCT Identifier


Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments, including being refractory to a proteasome inhibitor, immunomodulatory agent and an anti-CD38 monoclonal antibody
  • Measurable disease as defined by one of the following: abnormal serum or M-protein levels; abnormal serum free light chain (FLC) assay; ≥ 30% clonal plasma cells in the bone marrow aspirate or biopsy sample
  • Pulse oximetry ≥ 92% on room air
  • Eastern Cooperative Oncology Group (ECOG) performance of 0 - 2
  • Be willing and able to comply with the study schedule and all study requirements
  • Willing to follow contraception guidelines

Exclusion Criteria:

  • Prior systemic anti-tumor therapy or an investigational drug within 5 half-lives or 4 weeks of D1, whichever is shorter, preceding the first dose of study drug
  • Prior treatment with allogeneic hematopoietic stem cell transplantation within 6 months, has active graft versus host disease following transplant or currently receiving immunosuppressive therapy following transplant
  • Diagnosis of other malignancies if the malignancy required therapy in the last 3 years or is not in complete remission
  • Current history of CTCAE Grade 3 muscle paresis or ocular disorders that are Grade 3 or 2
  • Has any clinically significant low baseline lab results for hemoglobin, platelet counts, and neutrophil counts at screening
  • Abnormal INR or aPTT, unless on a stable dose of an anticoagulant
  • Has ≥ Grade 3 neuropathy or Grade 2 neuropathy with associated pain
  • Has any clinically significant baseline lab results for creatinine clearance, serum aspartate aminotransferase, alanine aminotransferase, total bilirubin
  • New York Heart Association Class > 2
  • Left ventricular ejection fraction < 40%
  • Prolonged QTcF interval on a 12-lead electrocardiogram
  • Has active COVID-19 infection, and not present with symptoms within 4 weeks of study drug
  • Has an active bacterial, viral, or fungal infection
  • Has known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C
  • Is currently pregnant or breast feeding or planning on either during the study
  • Has any significant medical condition, abnormality, or psychiatric illness that would prevent study participation
  • Has any additional clinical history that would place the patient at an unacceptable risk if the patient participates in the study

US Trial Locations

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